3040 men with moderate to severe urinary symptoms and enlarged prostate glands were treated with 5 mg finasteride or placebo daily for four years in a randomised, double-blind trial of high quality. It involved clinic visits every four months for symptom scoring and clinical examination. Men with suspected or proven prostate cancer were excluded.

Benefits

Finasteride did its usual job of reducing symptom scores (an average fall of 3 points from a baseline of 15), prostate volume (by 18% on average over four years, compared with a 10% increase with placebo), and increasing urinary flow (by 2 mL/sec from a baseline of 11 mL/sec). But there were also data on men who progressed to acute retention, surgery, and on adverse effects. In the Table we give both the NNTs and NNHs, and the actual rates for benefits and harms.

Finasteride reduced the number of men with acute retention, either spontaneous or precipitated by previous surgery or urinary tract infection, with an NNT of 26. To prevent a man having surgery, the NNT was 18, and for both it was 15. So 15 men with BPH have to be treated with finasteride for four years to prevent one of them having surgery or acute urinary retention. These figures are the same as, or a better than those from an earlier, smaller, trial .

Harms

The report also gives good estimates of possible harms associated with treatment. For instance, in this group of men with a mean age of 64 years at baseline, about 9% became impotent over four years. But 13% became impotent with finasteride, giving a number needed to harm of 23. Other harms are given in the Table. The overall incidence of prostate cancer was 5% in each group in the intensive study.

Comment

This type of information is invaluable in informing men of their options if they have benign prostatic hyperplasia and moderate to severe symptoms. Some will want surgery, some medical treatment, while others will decide that the risks of harm from treatment outweigh the benefits for them. The great thing is that we can now begin to put numbers on the benefits and the harms - which makes it easier to give information to men, and for men to make decisions.

The Propecia home page, produced by the company itself, claims that nine out of ten men treated with the drug have improved or at least maintained hair.

Propecia is also the only pill that treats Male Pattern Hair Loss that has been approved by the FDA. The company claims that they put the drug through five years of experimental research prior to making it available to the general public in 1998.

It is interesting how some drugs gain FDA-approval and others that produce equally effective laboratory trials do not get the highly lucrative stamp of FDA approval. Perhaps Propecia had more aggressive lobbyists working the angles in Washington to lend it more support with the Federal Drug Administration.

It should also be seriously noted that the FDA does not have a spotless record in releasing safe drugs to the general population. Their stamp of approval grows more questionable each season as new drugs promoted by lobbyists from major drug companies gain approval. A stamp of approval from the FDA is not without its political implications or influences.

All of the above reflects several facts that you should realize, as a patient and consumer of a drug, which was only tested for five years prior to its availability. Propecia has had negative results in 2% of its users, due to the hormonal imbalance. It is also a drug that can cause irreparable damage to an unborn male fetus. For this reason, women of childbearing age should have absolutely no contact with this drug in any form.

Propecia’s reputation within the established, traditional medical community may be excellent and shining, but when there is no guarantee of its success. as is the case with Propecia, you will be glad to know it isn’t the only proven-by-test treatment on the market, and not even the most effective one, either.

The company claims that most men experience positive results when they have taken the drug between three and twelve months. It is only productive for two areas of the head: the top of the head and the middle front area. It has not been useful in maintaining or growing hair at the temples or in a receding hairline.

While the company home page on the web claims that nine out of ten men experience positive results with Propecia, not all studies have reached the same conclusion.

According to Consumer Review.net, a popular and trusted website that reviews many brand name hair loss treatments and rates them according to their reported success, Propecia’s record is not so great. The Consumer Review says that 66% of the men who have taken it for Male Pattern Hair Loss reported positive growth. It presently costs around $230 for a three-month supply.

The latest news on Male Pattern Hair Loss reveals: there are cutting-edge alternative treatments that work very well. These are the ones strictly organically produced from flora and fauna of living earth. And they have a higher success rate than 66%.

Propecia, in generic terms is known as Finasteride. It is known to help men that are dealing with male pattern hair loss, also known as DHT. This particular pattern of baldness and hair loss is known to directly affect men because of genetics that are inherited from both their mother and father. The genes cause the hormone of DHT to react with the enzymes that are located in the scalp and hair region. When this happens, hair begins to thin and eventually causes for it to fall out completely.

Propecia is a prescription medication that has proven to be more effective in men than in women. Propecia will interact with male pattern baldness by adding an androgen hormone as a possible treatment. This will then balance out with the enzymes and other chemicals that are causing hair loss.

Women must not use Propecia when they are pregnant or hoping to get pregnant. Propecia can potentially cause abnormalities of the male baby’s sex organs, a condition known as hypospadias. Additionally, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant.

Propecia is FDA approved drug for male pattern hair loss. Despite this, there are side effects to taking Propecia. Because of the added hormone, a small percentage of men have reported less desire for sex and difficulty in achieving an erection and/or a decrease in the amount of semen.

There may also be possible allergic reactions that occur, which can be noted from rashes, itching or irritation that takes place. If you should observe any of these symptoms, it is best to stop taking the medication and ask your doctor before you continue with the prescription.

Propecia is one of the several medications that are available for those dealing with male pattern hair loss. Consult your doctor to find out more about Propecia if you are interested to use this medication to help you in your treatment of falling hair. Knowing what your options are and evaluating your risks, will ensure that you make the best choice possible for treating your male pattern hair loss.

Allergies?Tell your doctor if you have ever had any unusual or allergic reaction to finasteride generic form. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy?Women who are or may become pregnant should not take finasteride or should not be exposed to broken or crushed finasteride tablets, because it can cause changes in the genitals (sex organs) of male fetuses.

Older adults?This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines?Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine
Women who are or who may become pregnant should not handle crushed generic finasteride tablets. There is a risk that the medicine could get into the pregnant woman’s body and cause birth defects in a male fetus.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

DHT is formed by the action of the enzyme 5-alpha reductase on testosterone. Finasteride is a drug that works by blocking the enzyme 5-alpha reductase Type II that converts testosterone to dihydrotestosterone (DHT) in the hair follicle. Propecia, the brand name for finasteride, is the only FDA approved oral medication for hair loss.
Finasteride causes a significant drop in both scalp and blood levels of DHT and its effect is felt to be related to both of these factors. Finasteride 1-mg/day decreases serum DHT levels by almost 70%. Serum testosterone levels actually increased by 9%, but this is within the range of normal.

It is commonly thought that finasteride was first conceived as a prostate medication and that, only by chance, was found to prevent hair loss. The fact is that in 1974 the researcher Imperato-McGinley described a group of genetically male children from the village of Salinas in the Dominican Republic who were deficient in the enzyme 5-alpha reductase. These male children had very low levels of DHT and throughout their life, their prostates remained small and they did not develop male pattern hair loss or acne.

The objective of the researchers was to find a drug that could block the 5-alpha reductase enzyme and mimic the abnormality found in these men. They could then use this drug to prevent both prostate enlargement (BPH) and hair loss. The decision was made, however, to obtain FDA approval for the medical indication first, rather than the cosmetic one. As a result, in 1992, Finasteride 5-mg was released under the brand name Proscar, for use in men over 50 with prostate enlargement (the prostate also has the type II enzyme). Five years later, i n 1997, the FDA approved finasteride 1-mg/day (Propecia) for the treatment of male pattern baldness.
Side Effects
Side effects from finasteride at the 1-mg dose are uncommon, but reversible. The one- year drug related side effects were 1.5% greater than in the control group. The data showed that 3.8% of men taking finasteride 1mg experienced some form of sexual dysfunction verses 2.1% in men treated with a placebo. The five-year side effects profile included: decreased libido (0.3%), erectile dysfunction (0.3%), and decreased volume of ejaculate (0.0%).

Most reported cases of sexual dysfunction occurred soon after starting the medication, but there have been reports of sexual dysfunction that have occurred at later points in time. The sexual side effects were reversed in all men who discontinued therapy, and in 58% of those who continued treatment. After the medication was stopped, side effects generally disappeared within a few weeks. When finasteride is discontinued, only the hair that had been gained or preserved by the medication is lost. In effect, the patient returns to the level of balding where he would have been had he never used the drug in the first place. No drug interactions of clinical importance have been identified.
Generic Finasteride
Finasteride 5mg (Proscar) is available in a generic formulation. (Propecia) will not be available generically until the year 2012. For those wanting to take generic finasteride, we recommend buying a pill cutter at the pharmacy and taking � of a 5mg tablet every day. Please be advised that there is no scientific data insuring that this will be as effective as Propecia 1mg a day. Also, remember that there is a potential risk to pregnant women from handling broken or crushed tablets (see Caution during Pregnancy).
Patient Monitoring
It is recommended that men aged 50, or over, should inform their regular physicians or urologists that they are taking Propecia (finasteride 1mg). It is also recommended that all men aged 50 or over have a routine annual evaluation for prostate disease, regardless of whether or not Propecia is used. For those patients who are black and/or who have a family history of prostate disease, these recommendations would apply beginning at age 40. An evaluation may include a rectal examination, a baseline PSA, and other tests that your examining physician feels are appropriate.

The Prostate Cancer Prevention Trial (PCPT) showed at a dosage of 5mg per day, as is commonly prescribed for BPH, though much higher than the 1mg generally prescribed for hair loss, participants taking finasteride were 25% less likely to have developed prostate cancer at the end of the trial compared to those taking a placebo.[1] Further, finasteride increased the specificity and selectivity of prostate cancer detection, thus, a seemly increased rate of high Gleason grade tumor.

Recognized side effects, experienced by around >1% of users, include erectile dysfunction, and less often gynecomastia (breast gland enlargement). [4] As expected from its short 6-8 hour half-life, in trial studies, side effects ceased after dosage was discontinued.
Brand names

Drug trade names include  Propecia and Proscar, both products of Merck & Co. (the former is marketed for hair loss in male pattern baldness, and the latter for BPH). There is 1 mg of finasteride in Propecia and 5 mg in Proscar.

Cipla also manufactures finasteride (trade names Fincar and Finpecia), as does Dr. Reddy’s (trade names Finax and Finast), Ranbaxy (trade name Finara), Intas (trade name Finalo), and Aleppo Pharmaceutical (trade name Prosteride), who sell the drug at a significantly lower cost than Merck.

Side effects

Finasteride is not indicated for use by women. Finasteride is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Women who are or who may become pregnant must not handle crushed or broken finasteride tablets, because the medication could be absorbed through the skin. Finasteride is known to cause birth defects in a developing male baby. Exposure to whole tablets should be avoided whenever possible, however exposure to whole tablets is not expected to be harmful as long as the tablets are not swallowed. It is not known whether finasteride passes into breast milk, and thus should not be taken by breastfeeding women. Finasteride may pass into the semen of men, but Merck states that a pregnant woman’s contact with the semen of a man taking finasteride is not an issue for concern.[2]

Finasteride has been linked with depression [3] The drug also caused reductions in allopregnanolone, a potent, endogenous positive modulator of the GABA-A receptor, in very large doses in rodent studies.[4]

Finasteride can also be used to mask steroid abuse, and many professional sports have banned finasteride use for this reason. [5]

Finasteride is under investigation by the Swedish Medical Products Agency for possibly causing irreversible sexual side effects [6].

Use as a treatment for hair loss

In a 5-year study of men with mild to moderate hair loss, 48% of those treated with Propecia (finasteride 1mg) experienced some regrowth of hair, and 42% had no further loss. Average hair count in the treatment group remained above baseline, and showed an increasing difference from hair count in the placebo group, for all five years of the study.[5]. Propecia is effective only for as long as it is taken; the hair gained or maintained is lost within 6-12 months of ceasing therapy (Rossi, 2004). In clinical studies, Propecia, like minoxidil, was shown to work on both the crown area and the hairline,[7] but is most successful in the crown area.

Some users, in an effort to save money, buy Proscar instead of Propecia, and split the Proscar pills to approximate the Propecia dosage. Doing so is generally considered unadvisable if women of pregnancy age are in the household; this is because finasteride, even in small concentrations, can cause birth defects in a developing male fetus. The birth defects involve the development of male genitalia (no such effects have been noted in developing female fetuses). On most product inserts, it will be mentioned that the dust or crumbs from broken Propecia tablets should be kept away from pregnant women.

Propecia has been shown to be ineffective for treating hair loss in women.[citation needed] However, Propecia’s supporters respond that the study was on post-menopausal women whose hair loss was more likely related to the loss of estrogen versus a sensitivity to testosterone. Many doctors prescribe it for women, but not without either careful birth control measures or assurance that the woman cannot become pregnant.

Possible health concerns

The UC Berkeley Wellness Letter expressed concern in March 2003 about the unproven long-term safety of Propecia and recommended cutting a standard 1 milligram dose of Propecia into quarters to reduce the cost without reducing its effectiveness. This claim appears to be supported by clinical pharmacological data reviewed by the FDA during Propecia’s approval process that suggested that the advantage of taking 1 mg per day over 0.2 mg per day is statisticially small.[8] Some people have unsuccessfully petitioned the FDA to re-examine the approved dosage in light of the statistical evidence and unknown long-term risks.[9] The FDA responded and said that just because the level of DHT found in the scalp was not significantly different does not mean there is a correlation with hair loss. A study would have to show that the benefits of using 0.2 mg and 1 mg were not statistically different. According to the FDA such a study has been performed and a 1 mg dose has a greater benefit whilst remaining equally safe. The same study also concluded that doses of 0.01 mg per day were found to be ineffective in treating hair loss.[9]

In the Prostate Cancer Prevention Trial (PCPT), 25 percent fewer men taking the drug finasteride developed prostate cancer than men not taking the drug. However, men who developed prostate cancer while taking finasteride were more likely to have high-grade cancers, which can spread quickly even if the tumors are small. [10]

Propecia’s effects in detail

DHT is a derivative hormone (metabolite) of testosterone that has been shown to be critical to the initiation and progression of follicular miniaturization and eventual destruction of hair follicles in male pattern baldness. DHT is a steroid hormone just like testosterone but with greater affinity for the androgen receptor. Converting testosterone to DHT thus increases many of its effects.

While the mechanism by which DHT is involved in hair loss is not confirmed, many dermatologists and research scientists specializing in hair loss believe DHT molecules may diffuse into the interior of hair follicle cells (the cytoplasm or cytosol) and bind with androgen receptors. This complex, both the receptor and the DHT molecule, then enters the nucleus of the cell. In the nucleus of the hair follicle cell this complex could then alter the rate of protein synthesis in men who are genetically predisposed to baldness. [citation needed]

However, DHT also plays an important role in the functioning of the central nervous system (the brain), the testicles and prostate, and almost everything but muscle tissue. In muscle tissue testosterone is the dominant hormone, which is why some bodybuilders inject testosterone derivatives to aid in muscular development.

* Propecia (and other products containing finasteride) cause a rise in testosterone levels because testosterone that would normally be converted into DHT remains testosterone. Continual high levels of testosterone in the body could possibly have negative side effects.

* Artificially low levels of DHT in the body could cause some unwanted conditions. DHT is an antagonist of estrogen. Men’s bodies also produce the female hormone estrogen in the adrenal glands, although this is just one-tenth of the estrogen that premenopausal women produce in their ovaries. By reducing DHT with drugs, a man’s protection from the effects of estrogen may also be reduced. This could result in gynecomastia.

* Even though both finasteride and dutasteride were developed to combat benign prostatic hyperplasia by reducing DHT in prostate tissue, some scientists question the wisdom of using these 5-alpha reductase inhibitors in younger men who have no problem with their prostates. A research chemist, Patrick Arnold, says “Evidence is mounting that the existence of a high estrogen/androgen ratio – a condition common in older men – is highly correlated with the development of benign prostatic hyperplasia.”[citation needed] However, in apparent contradiction, individuals with 5-alpha-reductase deficiency (and thus a similar hormonal profile to users of DHT inhibitors) do not experience BPH

 Why is this drug prescribed?

Flomax / Flomaxtra is used to treat the symptoms of an enlarged prostate–a condition technically known as benign prostatic hyperplasia or BPH. The walnut-sized prostate gland surrounds the urethra (the duct that drains the bladder). If the gland becomes enlarged, it can squeeze the urethra, interfering with the flow of urine. This can cause difficulty in starting urination, a weak flow of urine, and the need to urinate urgently or more frequently. Flomax / Flomaxtra doesn’t shrink the prostate. Instead, it relaxes the muscle around it, freeing the flow of urine and decreasing urinary symptoms.
Most important fact about this drug

Flomax / Flomaxtra can cause dizziness, especially when you first stand up. Be careful about driving, operating machinery, and performing any other hazardous task until you know how you react to the drug.
How should you take this medication?

Take Flomax / Flomaxtra once daily, half an hour after the same meal each day. Do not crush, chew, or open the capsule.
If you miss a dose

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

If you miss several doses in a row, resume treatment with a dose of 1 capsule daily and check with your doctor on how to proceed.
Storage Instructions

Store at room temperature, below 25°C (77°F).
What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Flomax.

Side effects may include:

* abnormal ejaculation
* back pain
* chest pain
* cough
* diarrhea
* dizziness
Why should this drug not be prescribed?

If Flomax / Flomaxtra gives you an allergic reaction, you cannot take the drug.
Special warnings about this medication

Remember that, in a few men, Flomax / Flomaxtra can cause a drop in blood pressure upon first standing up, which in turn can lead to dizziness or fainting. Avoid driving and other hazardous tasks for 12 hours after your first dose or a dosage increase, and be careful to stand up slowly until you’re sure the drug won’t make you dizzy. If you do become dizzy, sit down until it passes.

Although the problem is extremely rare (affecting perhaps 1 in 50,000) Flomax has been known to cause priapism–a painful, persistent erection unrelated to sexual activity. If you develop this side effect, call your doctor without delay. The condition can lead to permanent impotence if not treated immediately.

Flomax / Flomaxtra is for use only by men.
Possible food and drug interactions when taking this medication

If Flomax / Flomaxtra is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Flomax / Flomaxtra with any of the following:

* Blood pressure drugs classified as alpha-blockers, such as Catapres
* Cimetidine (Tagamet)
* Warfarin (Coumadin)

Merck Pharmaceuticals sought to find the smallest effective quantity of finasteride and test its long term effects on 1,553 men between ages 18 and 41 with mild to moderate thinning of hair. Based on their research, 1mg daily was selected, and after 2 years of daily treatment, over 83% of the 1,553 men had actually maintained or increased their hair count from baseline. Visual assessments concluded that over 80% had improved appearances.

Finasteride (Proscar) 5mg was split into fifths and bottled as a 1mg daily treatment for hair loss called Propecia. A prescription is required to obtain this treatment.

Propecia, like Proscar, is the newest clinically proven treatment on the market for men experiencing hair loss. It also has the longest, most successful run of any treatment to have undergone FDA trials. At the writing of this review, the original 2 year trials are approaching their 6th year, and the vast majority of participants are still maintaining hair counts.

Who is this Treatment for?

Propecia is only approved for use in Men over the age of 18.

    What is it used for?

Propecia’s main purpose is to stop hair loss from progressing, and to maintain what hair one has left.

In clinical trials, it did increase hair count in over 60% of men, but only about 42% had any noticeable improvement. Propecia is commonly used by younger men wishing to stop the progression of their hair loss, and it is phenomenally good at accomplishing this goal. It is also commonly used as a part of a combination treatment regimen with Minoxidil 2% and 5% by men who already have extensive hair loss.

    Propecia’s Method of Action

Testosterone floating in the bloodstream of the typical adult male routinely combines with an enzyme called 5-alpha reductase. The result of this interaction forms the more potent sexual hormone known as DHT (Dihydrotestosterone). DHT plays a primary role in proper sexual organ development during the fetal stage of life, as well as the proper development of secondary male characteristics during puberty.
When a man begins to lose his hair, certain genetically programmed follicles begin to develop DHT receptor sites. The DHT attaches itself to these receptor sites and begins to treat the follicle as a foreign object in the body. This chemical change not only affects hair, can cause itching, inflammation, and oiliness. During this time, the follicle, under the attack of DHT, begins to miniaturize with every growth cycle, until after several years, it simply is too small and short to be seen.

When Propecia is taken, it works to inhibit the formation of DHT in the system. Within a few months, the overall DHT levels will have remained low enough on a constant basis that the adverse effects DHT is having on the follicles will stop, resulting in a cessation of hair loss.

What’s in it?

Propecia contains 1mg of Finasteride, a systemic DHT inhibitor which has been used for over 20 years at five times the dosage (in the form of Proscar) to help treat men with Benign Prostate Hyperplasia (BPH).

Propecia side effects

The great thing about this treatment is that you can take it for a month to see how well you tolerate it. If you notice any problems and wish to discontinue, you may do so without having done yourself any harm. Those who do experience side effects will also be happy to know that these side effects are very common at the beginning of treatment while your system is adjusting itself, and typically disappear after a couple months.

It is important that those with liver function problems consult a physician prior to taking Propecia, as it is extensively metabolized in the liver.

How to use Propecia

Propecia should be administered at 1mg daily in pill form, with no exceptions. Many people talk about custom dosing, skipping days, doubling up, etc. This will not only do nothing to help your hair loss, but will also do your system more harm than good. Hormones are very delicate chemicals that operate in conjunction with each other Therefore a constant daily dose will ensure a stable hormonal environment, and keep your biology in harmony.

It is a little known fact that the FDA trial participants all used a shampoo like Nizoral for the duration of the trial. This was required, as the increased sebum production, inflammation, and irritation caused by the balding process can limit the effectiveness of any treatment. This is why it is STRONGLY recommended that a regimen including Propecia also include Nizoral shampoo used once every 3 days in rotation with your normal shampoo. You will not see optimum results without Nizoral, or a shampoo like it, in your regimen.